Is the increasing use of evidence-based pharmacotherapy causing the renaissance of complementary medicine?

Vozeh S.

Prescription Medicines, Veterinary Medicines and Pharmacovigilance, Swissmedic, Swiss Agency for Therapeutic Products, Erlachstrasse 8, CH-3000 Berne 9, Switzerland.

This brief commentary considers a possible hitherto infrequently discussed factor that might contribute to the increase in the use of complementary medicines: the difficulties of using placebo within the context of evidence-based medicine, which represents the current standard for pharmacotherapy in most western culture countries. It discusses the possibility of placebo having a similar or better benefit-risk profile compared with an active compound in some diseases, and shows three examples in which this can be concluded from a clinical trial (insomnia, allergic rhinitis, irritable bowel disease). It is proposed that complementary medicine has under these circumstances taken the place of placebo therapy. By this, the commentary does not deny (and does not discuss) the possibility of an effect of complementary medicines other than the placebo effect. However, it recognizes that complementary medicine is open to the therapeutic application of the placebo effect by using a medicine with the claim that it has worked in similar situations and may work in the actual patient, without requiring hard data showing superiority to placebo. Physicians might be more open to the use of complementary medicines for indications in which the placebo effect is high, the conventional therapy carries a risk of side-effects and the omission of treatment with a pharmacologically active compound does not result in irreversible damage. The regulators on their part should probably not require proof of effectiveness compared with placebo in controlled clinical trials. However, whenever used in this sense, the complementary medicine product must unequivocally demonstrate its safety with respect to both the ingredients and the pharmaceutical quality. This is unfortunately not always the case.

PMID: 12919177 [PubMed - in process]

The long-term effects of auricular therapy using magnetic pearls on elderly with insomnia.

Suen LK, Wong TK, Leung AW, Ip WC.

School of Nursing, The Hong Kong Polytechnic University, Hong Kong, HungHom, PR China. hslsuen@polyu.edu.hk

OBJECTIVE: To examine the long-term effect of auricular therapy using magnetic pearls administered for the elderly suffering from insomnia. DESIGN: A follow-up study after a randomized controlled trial. SETTINGS: Four hostels for the elderly in Hong Kong. INTERVENTIONS: This paper focuses on reporting the long-term effect of auricular therapy using magnetic pearls in the experimental group of a randomized controlled study. Fifteen volunteer participants were followed up at 1-, 3-, and 6-month intervals after a 3-week treatment course. OUTCOME MEASURES: Objective sleep parameters using actigraphic monitoring were collected at different intervals of time after the therapy. RESULTS: Results of RANOVA demonstrate that there was a significant difference of nocturnal sleep time (F(2.30,29.90)=3.63, P<0.05) and marginally differences of sleep efficiency (F(4,52)=2.52, P=0.05) at baseline, immediately after the therapy, and at the three time intervals at 1, 3 and 6 months. The results illustrate that the mean nocturnal sleep time (F=4.95, P=0.30, R(2)=0.91) and the mean sleep efficiency (F=13.50, P=0.19, R(2)=0.96) also remained constant over the 6-month follow up period. The results of least square polynomial regression analysis also illustrate that the mean NST (F=4.95, P=0.30, R(2)=0.91) and the mean sleep efficiency (F=13.50, P=0.19, R(2)=0.96) remained constant over the 6-month follow up period. CONCLUSION: The results of this follow up study indicate that auricular therapy using magnetic pearls could have a long-term effect, at least within the observed period of time, on improving the quality as well as the quantity of sleep among the elderly.

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PMID: 12801493 [PubMed - indexed for MEDLINE]

Mind-body medicine: state of the science, implications for practice.

Astin JA, Shapiro SL, Eisenberg DM, Forys KL.

California Pacific Medical Center, San Francisco 94115, USA.

BACKGROUND: Although emerging evidence during the past several decades suggests that psychosocial factors can directly influence both physiologic function and health outcomes, medicine had failed to move beyond the biomedical model, in part because of lack of exposure to the evidence base supporting the biopsychosocial model. The literature was reviewed to examine the efficacy of representative psychosocial-mind-body interventions, including relaxation, (cognitive) behavioral therapies, meditation, imagery, biofeedback, and hypnosis for several common clinical conditions. METHODS: An electronic search was undertaken of the MEDLINE, PsycLIT, and the Cochrane Library databases and a manual search of the reference sections of relevant articles for related clinical trials and reviews of the literature. Studies examining mind-body interventions for psychological disorders were excluded. Owing to space limitations, studies examining more body-based therapies, such as yoga and tai chi chuan, were also not included. Data were extracted from relevant systematic reviews, meta-analyses, and randomized controlled trials. RESULTS: Drawing principally from systematic reviews and meta-analyses, there is considerable evidence of efficacy for several mind-body therapies in the treatment of coronary artery disease (eg, cardiac rehabilitation), headaches, insomnia, incontinence, chronic low back pain, disease and treatment-related symptoms of cancer, and improving postsurgical outcomes. We found moderate evidence of efficacy for mind-body therapies in the areas of hypertension and arthritis. Additional research is required to clarify the relative efficacy of different mind-body therapies, factors (such as specific patient characteristics) that might predict more or less successful outcomes, and mechanisms of action. Research is also necessary to examine the cost offsets associated with mind-body therapies. CONCLUSIONS: There is now considerable evidence that an array of mind-body therapies can be used as effective adjuncts to conventional medical treatment for a number of common clinical conditions.

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PMID: 12665179 [PubMed - indexed for MEDLINE]

Neurobehavioural performance effects of daytime melatonin and temazepam administration.

Rogers NL, Kennaway DJ, Dawson D.

Division of Sleep and Chronobiology, Unit for Experimental Psychiatry, The University of Pennsylvania School of Medicine, Philadelphia, PA 19104-6021, USA. nrogers2@mail.med.upenn.edu

Exogenous melatonin is a potential treatment for circadian disruption and insomnia. Hence, it is important to determine and quantify neurobehavioural performance effects associated with its use. The present study compared neurobehavioural performance following administration of melatonin and the benzodiazepine temazepam, using a within-subjects design. Following a training day, 16 healthy, young subjects (six males, 10 females; mean age +/- SEM, 21.4 +/- 6 years) participated in a 3-day protocol. After sleeping overnight in the laboratory, subjects completed a battery of tests at hourly intervals between 08:00 and 11:00 hours and at two hourly intervals between 13:00 and 17:00 hours. The neurobehavioural performance tasks included: unpredictable tracking, spatial memory, vigilance and logical reasoning. Subjective sleepiness was measured at hourly intervals using a visual analogue scale. At 12:00 h subjects were administered a capsule containing 5 mg melatonin, 10 mg temazepam or placebo, in a randomized, double-blind crossover fashion. A significant drug x time interaction was evident on the unpredictable tracking, spatial memory and vigilance tasks (P < 0.05). Greater changes in performance were evident following temazepam administration than melatonin administration, relative to placebo. Administration of melatonin or temazepam significantly elevated subjective sleepiness levels, relative to placebo (P </= 0.05). The present findings demonstrate that melatonin administration induces a smaller deficit in performance on a range of neurobehavioural tasks than temazepam. Given melatonin's soporific and chronobiotic properties, these results suggest that melatonin may be preferable to benzodiazepines in the management of circadian and sleep disorders.

PMID: 12941059 [PubMed - in process]

Is there a rationale for prescription of benzodiazepines in the elderly? Review of the literature.

Petrovic M, Mariman A, Warie H, Afschrift M, Pevernagie D.

Service of Internal Medicine, Ghent University Hospital, De Pintelaan 185, B-9000 Ghent, Belgium. mirko.petrovic@rug.ac.be

Benzodiazepines (BZDs) constitute the most widely used symptomatic treatment of insomnia and anxiety. Many of these drugs are associated with adverse effects, such as daytime sedation and dependence with continued use. There is a concern about the rationale for and extent of benzodiazepine (BZD) use in the elderly. The sedation due to BZD use is a main risk factor for falls and other accidents. Impaired cognitive function with continuous use appears to be a major side effect. There is a general awareness that BZD use is inappropriate in many patients, and therefore discontinuation should be recommended whenever possible. Moreover, long-term use of these drugs should be actively discouraged. Although no unanimous recommendations concerning the optimal duration of the withdrawal process exist, BZDs may easily be withdrawn during a short period in most patients who are habituated to a low dose, if an initial phase with dose reduction and psychological support are provided. Alternative approaches involve sleep hygiene guidelines, behavioural treatment and psychotherapy tailored to the needs of the individual patient.

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PMID: 12723259 [PubMed - indexed for MEDLINE]

Benzodiazepines and related drugs for insomnia in palliative care.

Hirst A, Sloan R.

Cochrane Cancer Network, Institute of Health Sciences, P O Box 777, Headington, Oxford, UK, OX3 7LF. ahirst@canet.org

BACKGROUND: Insomnia, a subjective complaint of poor sleep and associated impairment in daytime function, is a common problem. Currently, benzodiazepines are the most used pharmacological treatment for this complaint. They are considered helpful for occasional short-term use up to four weeks but longer term use is not advised due to potential problems regarding tolerance, dosing escalation, psychological addiction and physical dependence. There is no consensus on their utility in patients with progressive incurable conditions who may require assistance with sleep for many weeks as their condition deteriorates. OBJECTIVES: To assess the effectiveness and safety of benzodiazepines or benzodiazepine receptor agonists such as Zolpidem, Zopiclone and Zaleplon for insomnia in palliative care. SEARCH STRATEGY: Several electronic databases were searched including Cochrane PaPaS Group specialized register, Cochrane Library Issue 4, 2001, MEDLINE, EMBASE, BNI plus, CINAHL, BIOLOGICAL ABSTRACTS, PSYCINFO, CANCERLIT, HEALTHSTAR, WEB OF SCIENCE, SIGLE, Dissertation Abstracts, ZETOC and the MetaRegister of ongoing trials. These were searched from 1960 to 2001 or as much of this range as possible. Additional articles were sought by handsearching reference lists in standard textbooks and reviews in the field and by contacting academic centres in palliative care and pharmaceutical companies. There were no language restrictions. SELECTION CRITERIA: Studies considered for inclusion were randomized controlled trials of adult patients in any setting, receiving palliative care or suffering an incurable progressive medical condition. (For example, cancers, AIDS, Motor Neurone Disease, Multiple Sclerosis, Parkinson's Disease, Chronic Obstructive Pulmonary Disease). There had to be an explicit complaint of insomnia in study participants, diagnosed by any of the three main classification systems (DSM-IV (APA 1994), ICSD (AASD 1990) or ICD (WHO 1992)), or as described in the study if it involved a subjective complaint of poor sleep. Studies had to compare a benzodiazepine or Zolpidem or Zopiclone or Zaleplon with placebo or active control for the treatment of insomnia. Any duration of therapy were considered. DATA COLLECTION AND ANALYSIS: Abstracts were independently inspected by both reviewers, full papers were obtained where necessary. Where there was uncertainty advice was sought by a third (PW). Data extraction and quality assessments were undertaken independently by both reviewers. MAIN RESULTS: No randomized controlled trials were identified meeting the a priori inclusion criteria. Thirty-seven studies were considered but all were excluded from the review. REVIEWER'S CONCLUSIONS: Despite a comprehensive search no evidence from randomized controlled trials was identified. It was not possible to draw any conclusions regarding the use of benzodiazepines in palliative care.

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PMID: 12519593 [PubMed - indexed for MEDLINE]

Anxiety, depression, and insomnia.

Larzelere MM, Wiseman P.

Department of Family Medicine, Louisiana State University Health Sciences Center, School of Medicine, 200 West Esplanade Avenue, Suite 510, Kenner, LA 70065, USA. mlarze@lsuhsc.edu

Evidence for alternative treatments for depression, anxiety, and insomnia are reviewed in this article. Treatment of depression with St. John's wort, L-tryptophan, 5-hydroxytryptophan, S-adenosylmethionine, dehydroepiandosterone, folate, exercise, acupuncture, and meditation are examined. Evidence for the efficacy of kava kava, exercise, relaxation therapies, and acupuncture in treatment anxiety is reviewed. The use of valerian, melatonin, chamomile, passionflower, exercise, acupuncture, and behavioral therapies (i.e., sleep restriction, stimulus control, relaxation, and sleep hygiene) for insomnia is discussed.

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PMID: 12391715 [PubMed - indexed for MEDLINE]

Can valerian improve the sleep of insomniacs after benzodiazepine withdrawal?

Poyares DR, Guilleminault C, Ohayon MM, Tufik S.

Sleep Laboratory of the Department of Psychobiology, Universidade Federal de Sao Paulo, Sao Paulo, Brazil.

PURPOSE: The authors studied the sleep of patients with insomnia who complained of poor sleep despite chronic use of benzodiazepines (BZDs). The sample consisted of 19 patients (mean age 43.3+/-10.6 years) with primary insomnia (DSM-IV), who had taken BZDs nightly, for 7.1+/-5.4 years. The control group was composed of 18 healthy individuals (mean age 37+/-8 years). Sleep electroencephalogram (EEG) of the patients was analyzed with period amplitude analysis (PAA) and associated algorithms, during chronic BZD use (Night 1), and after 15 days of a valerian placebo trial (initiated after washout of BZD, Night 2). Sleep of control subjects was monitored in parallel. RESULTS: Valerian subjects reported significantly better subjective sleep quality than placebo ones, after BZD withdrawal, despite the presence of a few side effects. However, some of the differences found in sleep structure between Night 1 and Night 2 in both the valerian and placebo groups may be due to the sleep recovery process after BZD washout. Example of this are: the decrease in Sleep Stage 2 and in sigma count; the increase in slow-wave sleep (SWS), and delta count, which were found to be altered by BZD ingestion. There was a significant decrease in wake time after sleep onset (WASO) in valerian subjects when compared to placebo subjects; results were similar to normal controls. Nonetheless, valerian-treated patients also presented longer sleep latency and increased alpha count in SWS than control subjects. CONCLUSIONS: The decrease in WASO associated with the mild anxiolytic effect of valerian appeared to be the major contributor to subjective sleep quality improvement found after 2-week of treatment in insomniacs who had withdrawn from BDZs. Despite subjective improvement, sleep data showed that valerian did not produce faster sleep onset; the increase in alpha count compared with normal controls may point to residual hyperarousabilty, which is known to play a role in insomnia. Nonetheless, we lack data on the extent to which a sedative drug can improve alpha sleep EEG. Thus, the authors suggest that valerian had a positive effect on withdrawal from BDZ use.

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PMID: 11999905 [PubMed - indexed for MEDLINE]

Kava and valerian in the treatment of stress-induced insomnia.

Wheatley D.

Psychopharmacology Research Group, 10 Harley Street, London W1G 9PF, UK. wheatley@ukgateway.net

Kava and valerian are herbal remedies, claimed to have anxiolytic and sedative properties respectively, without dependence potential or any appreciable side-effects. In this pilot study, 24 patients suffering from stress-induced insomnia were treated for 6 weeks with kava 120 mg daily. This was followed by 2 weeks off treatment and then, 5 having dropped out, 19 received valerian 600 mg daily for another 6 weeks. Stress was measured in three areas: social, personal and life-events; insomnia in three areas also: time to fall asleep, hours slept and waking mood. Total stress severity was significantly relieved by both compounds (p < 0.01) with no significant differences between them; as was also insomnia (p < 0.01). The proportion of patients with no side-effects was 58% with each drug respectively and the 'commonest' effect was vivid dreams with valerian (16%), followed by dizziness with kava (12% ). These compounds may be useful in the treatment of stress and insomnia but further studies are required to determine their relative roles for such indications. Copyright 2001 John Wiley & Sons, Ltd.

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PMID: 11536390 [PubMed - indexed for MEDLINE]

An evaluation of Coffea cruda effect on rats.

Ruiz-Vega G, Perez-Ordaz L, Proa-Flores P, Aguilar-Diaz Y.

Instituto de Fisica y Matematicas, Universidad Michoacana, Morelia, Michoacan, Mexico.

To investigate the effect of the homeopathic medicine Coffea cruda on sleep pattern, it was orally administered to rats at the beginning of their waking period. EEG from the parietal region was recorded during their next sleep cycle. Applying an FFT algorithm, spectral in the delta band, 0.5-2.5 Hz, was chosen as a marker parameter, evaluated for control and verum groups using a double-blind protocol. Power in the verum group was statistically higher than baseline value, it was not statistically different in the control group. The results indicate that an enhancement in EEG slow delta activity is associated with Coffea cruda.

PMID: 10939767 [PubMed - indexed for MEDLINE]

Herbal medications for common ailments in the elderly.

Ernst E.

Department of Complementary Medicine, School of Postgraduate Medicine and Health Sciences, University of Exeter, England. E.Ernst@exeter.ac.uk

The popularity of herbal medicine is at an all time peak. This article provides an overview of systematic reviews of herbal treatments for conditions common in elderly individuals. According to this evidence, there is little doubt that Hypericum perforatum (St John's Wort) is well tolerated and effective for mild to moderate depression. Although widely used, Valeriana officinalis (valerian) has not been shown beyond reasonable doubt to be effective for insomnia. There is relatively compelling evidence that Ginkgo biloba (ginkgo) is effective in delaying the clinical course of dementias. It has been well documented that Aesculus hippocastanum (horse chestnut) seed extracts alleviate the subjective symptoms and reduce the objective signs of chronic venous insufficiency. Serenoa repens (saw palmetto) is effective in improving the symptoms of benign prostatic hyperplasia. Finally, yohimbine has been shown to be effective forerectile dysfunction. It is concluded that several plant-based medicines can be useful additions to our therapeutic repertoire for treating common conditions in the elderly. However, several uncertainties remain and, at present, prevent unreserved recommendations.

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PMID: 10641953 [PubMed - indexed for MEDLINE

Use of complementary and alternative therapies to promote sleep in critically ill patients.

Richards K, Nagel C, Markie M, Elwell J, Barone C.

Central Arkansas Veterans Healthcare System, 2200 Fort Roots Drive, 3J/NLRVA, North Little Rock, AR 72114, USA. richardskathyc@uams.edu

The efficacy of complementary and alternative therapies for sleep promotion in critically ill patients is largely unexamined. We found only seven studies (three on environmental interventions and one each on massage, music therapy, therapeutic touch, and, melatonin) that examined the effect of complementary and alternative therapies. A number of studies, however, have shown that massage, music therapy. and therapeutic touch promote relaxation and comfort in critically ill patients, which likely leads to improved sleep. Massage, music therapy, and therapeutic touch are safe for critically ill patients and should be routinely applied by ICU nurses who have received training on how to administer these specialized interventions. Environmental interventions, such as reducing noise, playing white noise such as ocean sounds, and decreasing interruptions to sleep for care, also are safe and logical interventions that ICU nurses should use to help patients sleep. Progressive muscle relaxation has been extensively studied and shown to be efficacious for improving sleep in persons with insomnia; however, progressive muscle relaxation requires that patients consciously attend to relaxing specific muscle groups and practice these techniques, which may be difficult for critically 11 patients. We do not currently recommend aromatherapy and alternative sedatives, such as valerian and melatonin, for sleep promotion in critically ill patients because the safety of these substances is unclear. In summary, we recommend that ICU nurses implement music therapy, environmental interventions, therapeutic touch, and relaxing massage to promote sleep in critically ill patients. These interventions are safe and may improve patient sleep, although randomized controlled trials are needed to test their efficacy. Aromatherapy and alternative sedatives require further investigation to determine their safety and efficacy.

PMID: 12943139 [PubMed - indexed for MEDLINE